DQX · Wire, Guide, Catheter
Cardiovascular · 21 CFR 870.1330 · Class 2
Overview
| Product Code | DQX |
|---|---|
| Device Name | Wire, Guide, Catheter |
| Regulation | 21 CFR 870.1330 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.
Classification Rationale
Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (20 of 763)
Showing 20 most recent of 763 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260544 | FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 | FMD Co., Ltd. | Mar 20, 2026 | SESE |
| K253746 | Enroute 0.014'' Transcarotid Guidewire | Lake Region Medical | Mar 19, 2026 | SESE |
| K253262 | EmeryGlide (EG18008901) | Nano4imaging GmbH | Mar 6, 2026 | SESE |
| K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) | Merit Medical Ireland, Ltd. | Jan 31, 2026 | SESE |
| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) | Merit Medical Ireland, Ltd. | Jan 21, 2026 | SESE |
| K252674 | Solo Pace Fusion System (SOLOFUSE1) | Solo Pace, Inc. | Jan 9, 2026 | SESE |
| K251596 | Lunderquist Extra Stiff Wire Guide | William Cook Europe Aps | Nov 9, 2025 | SESE |
| K250203 | SureAx-Guide | Sureax Medical, LLC | Oct 17, 2025 | SESE |
| K250031 | Amplatzer Guidewire | ABBOTT MEDICAL | Oct 3, 2025 | SESE |
| K251181 | Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT) | Merit Medical Ireland, Ltd. | Aug 29, 2025 | SESE |
| K250552 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | ABBOTT MEDICAL | Jul 25, 2025 | SESE |
| K250075 | Medtronic Stedi Extra Support Guidewire | Medtronic, Inc. | Jun 13, 2025 | SESE |
| K243733 | SION blue PLUS | Asahi Intecc Co., Ltd. | Apr 2, 2025 | SESE |
| K241962 | Crossloop | Asahi Intecc Co., Ltd. | Mar 27, 2025 | SESE |
| K242597 | CROSSLEAD 0.018inch | Asahi Intecc Co., Ltd. | Mar 5, 2025 | SESE |
| K241702 | CROSSLEAD 0.014inch | Asahi Intecc Co., Ltd. | Feb 6, 2025 | SESE |
| K241521 | Prelude Small O.D. Introducer Guide Wire | Merit Medical Systems, Inc. | Dec 10, 2024 | SESE |
| K242824 | PTFE Guidewire | Lake Region Medical | Dec 6, 2024 | SESE |
| K240818 | R2P Radifocus Glidewire Advantage | Terumo Corporation | Nov 26, 2024 | SESE |
| K240997 | Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire | ABBOTT MEDICAL | Nov 6, 2024 | SESE |
Top Applicants
- Asahi Intecc Co., Ltd. — 47 clearances
- Advanced Cardiovascular Systems, Inc. — 45 clearances
- Lake Region Mfg., Inc. — 31 clearances
- Scimed Life Systems, Inc. — 30 clearances
- Cordis Corp. — 25 clearances
